A new study, published in the Journal of Food Protection, found that spacing out samples over time, called “stratified” sampling, is better at catching risky pathogens like Cronobacter in powdered products, such as infant formula, than randomly sampling from the product as it is being produced. In addition, the study found that that while taking more samples of a product generally increases the chance of catching the pathogen, there is a point after which it is unlikely that additional sampling will increase safety.
All efforts were based on detecting a realistic hazard, here defined by testing samples from Cronobacter-contaminated batches produced in Europe in the 2010s, using the most current data available. The paper found that safety plans with 30 or more grab samples had a very high probability of detecting the hazard. And that there was a point of diminishing returns, such that very high sample numbers—for example, testing every can produced—would not be meaningfully more powerful.
“This shows that existing sampling and testing guidance is powerful, at least for the one hazard profile our team had access to for the study,” said project lead Matthew J. Stasiewicz of the University of Illinois Urbana-Champaign. “This also highlights the need for additional research and data-sharing efforts into patterns of contamination in current infant formula production, so that sampling and testing can be better matched to current needs.”
“In additional to analyzing scenarios we found relevant, we built a web app that allows industry stakeholders to simulate various sampling scenarios and gain deeper understanding of the effectiveness of sampling plans specific to their plants. With this knowledge, producers can proactively address risks and optimize current sampling practices,” added Minho Kim, lead author.
On March 8, the FDA sent a letter to manufacturers, packers, distributors, exporters, importers, and retailers involved in the manufacturing and distribution of powdered infant formula to share current safety information and call on the industry to take prompt action to improve processes and programs for the protection of our infants.
The agency notes that since the 2022 infant formula recalls and resulting shortages, it has been working to improve the resiliency of the infant formula supply by issuing multiple guidance documents intended to help facilitate the availability of safe and nutritionally adequate products in the U.S. marketplace through the exercise of enforcement discretion. The FDA has also taken steps to enhance the safety of powdered infant formula through the development of a Cronobacterprevention strategy, enhanced inspectional activities, increased engagement with the infant formula industry, and by pursuing regulatory action when appropriate.
In addition, over the past two months, food safety staff have been meeting regularly with manufacturers to further develop the prevention strategy to help prevent Cronobacter illness associated with consumption of powdered infant formula. The letter sent to manufacturers reflects the information the agency gained through interactions with industry as well as the latest available science on improving the microbiological safety of powdered infant formula.
The FDA called on members of the infant formula industry to use the information in the letter to take prompt action to improve processes and programs for the protection of infants. In addition to this call to action, Congress recently added new requirements for manufacturers aimed at mitigating supply chain disruptions through mandatory shortage notifications and risk management plans.
NACMCF is an advisory committee, established by the USDA, that provides impartial, scientific advice and/or peer reviews to federal food safety agencies for use in the development of an integrated national food safety systems approach.
The meeting is intended to help the committee gain scientific insight regarding Cronobacter infections, including recommendations for how public health authorities can better protect public health, as well as recommendations for food safety management practices that the food industry can implement to enhance the safety of powdered infant formula.
The meeting will be held virtually using Zoom. Attendees must pre-register to receive a join link, dial-in number, access code and unique Attendee ID. Attendees who would like to deliver comments during the meeting must register by November 8, 2022. Attendees who do not plan to speak at the public meeting may register at any time up to the day of the meeting. The meeting agenda is available on the FSIS events page.
The U.S. Department of Health and Human Services, Office of the Inspector General (OIG) has announced an audit of the FDA over its actions regarding the Abbott infant formula recall. The audit, announced on June 2, will “determine whether FDA followed the inspections and recall process for infant formula in accordance with Federal requirements.”
The OIG is specifically examining the FDA’s actions leading up to the infant formula recall at the Abbott facility in February 2022 to determine whether FDA followed applicable policies and procedures related to conducting inspections of the manufacturing facility and overseeing Abbott’s initiation of the infant formula recall.
The FDA released a timeline of its infant formula-related activities, showing that inspectors first became aware of issues including standing water and inadequate handwashing during a routine inspection at Abbott Nutrition’s Sturgis, Michigan, facility in September 2021—the same month that the FDA received the first consumer complaint report of Cronobacter illness in an infant from the Minnesota Department of Health.
One key area of frustration during Congressional hearings in May was the delay of action on a whistleblower report filed with the FDA Detroit District Office in October 2021. The complaint was not reviewed by FDA leadership until February 2002, “due to an isolated failure in FDA’s mailroom, likely due to COVID-19 staffing issues,” according to the FDA.
Additional inspections of the facility between January and March 2022 found “significant, fundamental sanitation, building and equipment issues.” Swabs taken during the inspections revealed six confirmed samples of Cronobacter. These findings led Abbott, on the recommendation of the FDA, to voluntarily cease production at the facility and recall potentially contaminated products. The contaminated formula has been linked to four hospitalizations and two deaths.
The OIG audit is scheduled to be completed in 2023.
Last week, 3M Food Safety announced their 3M™ Molecular Detection Assay 2 – Cronobacter was designated by AOAC International as Performance Tested Method (Certificate #101703). The assay is compatible with their Molecular Detection System, which uses isothermal DNA amplification and bioluminescence detection to test for pathogens.
Cronobacter, a type of bacteria commonly found in powdered foods, supplements and baby formula, can survive for almost two years and exposure to an infant can be life-threatening.
“While less well known than other foodborne pathogens like Listeria or Salmonella, Cronobacter is no less dangerous – particularly because it preys on some of the most vulnerable populations,” says 3M Global Marketing Manager Carolina Riba. “It’s a point of pride for our team that the tests we’ve made for the dangerous pathogen were recognized by an organization like AOAC International.”
Using approved protocols set by the AOAC Research Institute, 3M’s testing process used an independent laboratory. They tested the assay on powdered infant formula, powdered infant cereal, lactose powder and an environmental surface.
3M has announced that its Molecular Detection Assay 2 has won the Gold Edison Award in the diagnostic tools category. The 2017 Edison Awards recognize innovators that have had a positive impact globally. The assay platform is a next-generation of tests, which also previously won an Edison award.
The technology is powered by isothermal DNA amplification and bioluminescience detection to provide a faster molecular detection of pathogens. Its single assay protocol enables batch processing of up to 96 different samples simultaneously and can provide same-day results.
The platform can be used to identify Salmonella, Listeria, Listeria monocytogenes, and E.coli O157 in food or environmental samples, and Cronobacter in powdered infant formula.
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